Evaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness

Consciousness Disorders Clinical Trial

— ORGAR  

Official title:

Phase 2 Study of a New Mechanical Ventilation Weaning Strategy Governs by a Respiratory Behaviour Status Assessment for Patients With Altered Level of Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700869
• Other study ID #: P070204
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 18, 2008
• Last updated: October 4, 2011
• Start date: April 2008
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough.

Description:

Current guidelines for mechanical ventilation weaning do not apply for patients with altered level of consciousness. One major limitation is a failure of clinical assessment of the respiratory behaviour status of these patients that are not able to interact appropriately with the examiner. We propose a non-invasive method for the respiratory behaviour assessment of a patient under artificial ventilation that do not requires his participation. Our hypothesis is that, in case of normal respiratory behaviour status, it is possible to wean under security a patient despite his abnormal level of consciousness.We previously demonstrate that patients successfully wean by the clinical team also disclose a normal respiratory behaviour status while patients with weaning failure had abnormal respiratory behaviour. In the present study, we wonder to evaluate that a weaning strategy governs by respiratory behaviour status assessed by our method is safe. For this purpose, in this study, tracheal tube withdrawal is triggered by a recognition of a normal respiratory behaviour status assessed daily in patients under mechanical ventilation with an altered level of consciousness and a good tolerance to T tube challenge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Altered level of consciousness (-1 < RASS > +1)

• Mechanical ventilation ( > 72 hours)

• Withdrawal of sedative drugs (> 48 hours)

• T tube challenge tolerance

• Signed approval for the study by close relative or legal representative

Exclusion Criteria:

• Respiratory disease prior to the actual artificial ventilation requirement.

• Impairment of upper airway function prior to the actual artificial ventilation requirement.

• Pregnancy

• Minor

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Artificial Respiration
• Consciousness Disorders
• Wearing Off Effect

Intervention

Procedure:
• mechanical ventilation
mechanical ventilation

Locations

Country	Name	City	State
France	Anesthesia and CCM; Lariboisière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful mechanical ventilation weaning at 72 hours		72 hours	Yes
Secondary	Post tracheal tube withdrawal pneumonia at 72 hours		72 hours	Yes
Secondary	Rate of auto-extubation during patient's participation to the protocol		10 days	Yes